Cerebral embolic protection device utilization and outcomes in transcatheter aortic valve replacement: A nationally representative propensity matched analysis.

INTRODUCTION: In patients undergoing transcatheter aortic valve replacement (TAVR), cerebral embolic protection devices (CEPD) are used to possibly diminish the risk of periprocedural stroke. Trends and outcomes of CEPD usage in TAVR are not well characterized. METHODS: National readmission databases (NRD) 2017-2019 was used to identify hospital admissions for TAVR using ICD-10 codes, with versus without Sentinel CEPD. Primary outcomes of the study were in-hospital and 30-day stroke. Secondary outcomes include in-hospital mortality, 30-day mortality, 30-day readmission rate, and other procedural complications. We matched both cohorts using propensity score matching (PSM) and performed logistic regression to compute the odds ratios (ORs) and corresponding 95 % confidence intervals (CI). RESULTS: Out of 190,837 TAVR admissions in the United States, 10,643 (5.6 %) patients had TAVR with Sentinel CEPD. After propensity score matching, our cohort included 10,503 patients with CEPD and 10,541 without CEPD. Trends in CEPD utilization are noted in Fig. 1. In the PSM cohort, Sentinel CEPD was not associated with decreased risk of in-hospital stroke (1.9 % vs. 1.8 %, OR: 0.98, 95 % CI: 0.76-1.26, p = 0.88), 30-day stroke (2.1 % vs. 2.1 %, OR: 1.01, 95 % CI: 0.78-1.30, p = 0.96), or 30-day mortality (1.3 % vs. 1.0 %, OR: 0.74, 95 % CI: 0.51-1.07, p = 0.11) when compared to TAVR without CEPD. Other in-hospital and short-term outcomes post-TAVR were not impacted by Sentinel CEPD usage, including acute kidney injury, vascular complications, paravalvular leak, cardiogenic shock, circulatory support, or permanent pacemaker (Table 1). CONCLUSION: In this nationally representative cohort, Sentinel CEPD utilization during transfemoral TAVR for stroke prevention was not associated with reduced odds of in-hospital stroke, 30-day stroke, or 30-day mortality. Future studies should focus on optimizing patient selection for CEPD and establishing predictive models to identify the subset of TAVR patients with higher risk for periprocedural stroke who might benefit from CEPD.

Impact of COVID-19 pandemic on the volume, cost, and outcomes of cardiac electrophysiology procedures in the United States.

BACKGROUND: During the COVID-19 pandemic, professional societies recommended deferral of elective procedures for optimal resource utilization. OBJECTIVE: We sought to assess changes in procedural trends and outcomes of electrophysiology (EP) procedures during the pandemic. METHODS: National Inpatient Sample databases were used to identify all EP procedures performed in the United States (2016-2020) by International Classification of Diseases, Tenth Revision codes. We evaluated trends in utilization, cost/revenue, and outcomes from EP procedures performed. RESULTS: An estimated 1.35 million EP procedures (82% devices and 18% catheter ablations) were performed (2016-2020) with significant yearly uptrend. During the pandemic, there was a substantial decline in EP procedure utilization from a 5-year peak of 298 cases/million population in the second quarter of 2019 to a nadir of 220 cases in the second quarter of 2020. In 2020, the pandemic was associated with the loss of 50,233 projected EP procedures (39,337 devices and 10,896 ablations) with subsequent revenue loss of $7.06 billion. This deficit was driven by revenue deficit from dual-chamber permanent pacemaker (PPM) utilization ($2.88 billion, 49.3% of lost cases), ablation procedures ($1.84 billion, 21.7% of lost cases), and implantable cardioverter-defibrillator implantation ($1.36 billion, 12.0% of lost cases). To the contrary, there was a 9.4% increase in the utilization of leadless PPM. EP device implantation during the pandemic was associated with higher adverse in-hospital events (9.4% vs 8.0%; P < .001). CONCLUSION: In the United States, the significant decline in EP procedures during the pandemic was primarily driven by the reduction in dual-chamber PPM utilization, followed by arrhythmia ablation and implantable cardioverter-defibrillator implantation. There was a substantial increase in leadless PPM utilization during the pandemic.

Impact of concomitant surgical interventions on outcomes of septal myectomy in obstructive hypertrophic cardiomyopathy.

BACKGROUND: Septal myectomy (SM) is offered to symptomatic patients with obstructive hypertrophic cardiomyopathy (oHCM) despite medical therapy. Frequently, patients undergo concomitant planned or ad-hoc mitral valve replacement (MVR), aortic valve replacement (SAVR), or coronary artery bypass grafting (CABG). OBJECTIVES: We sought to assess characteristics and outcomes of patients with oHCM undergoing concomitant surgical interventions at the time of SM. METHODS: The National Readmission Databases were used to identify all SM admissions in the United States (2010-2019). Patients undergoing SM were stratified into: isolated SM (±MV repair), SM + CABG only, SM + MVR, SM + SAVR, and SM + MVR + SAVR. Primary outcomes were in-hospital mortality, in-hospital adverse events, and 30-day readmission. RESULTS: 12,063 encounters of patients who underwent SM were included (56.1% isolated SM, 9.0% SM + CABG only, 17.5% SM + MVR, 13.1% SM + SAVR, and 4.3% SM + MVR + SAVR). Patients who underwent isolated SM were younger (54.3 vs. 67.1 years-old, p < 0.01) and had lower overall comorbidity burden. In-hospital mortality was lowest in isolated SM, followed by CABG only, SM + SAVR, SM + MVR, and SM + SAVR+MVR groups (2.3% vs. 3.7% vs. 5.3% vs. 6.7% vs. 13.7%, p < 0.01), respectively. SM with combined surgical interventions was associated with higher adverse in-hospital events (24.3% vs. 11.1%, p < 0.01) and 30-day readmissions (16.9% vs. 10.4%, p < 0.01). MV repair performed concomitantly with SM was not associated with increased in-hospital mortality (3.9% vs. 3.4%, p = 0.72; aOR 0.99; 95% CI: 0.54-1.80, p = 0.97]) or adverse clinical events. CONCLUSIONS: In SM for oHCM, patients undergoing concomitant surgical interventions were characteristically distinct. Aside from MV repair, concomitant interventions were associated with worse in-hospital death, adverse in-hospital events, and 30-day readmission.

Trends and outcomes of lytic-based therapies for high-risk pulmonary embolism: A nationwide analysis.

BACKGROUND: Systemic thrombolysis (ST) is the guideline-recommended treatment for high-risk pulmonary embolism (PE), although catheter-directed thrombolysis (CDT) may provide a treatment alternative associated with lower rates of bleeding. Furthermore, the treatment trends and outcomes among those with high-risk PE according to treatment assignments of no lytic therapy (NLT), ST, and CDT are underreported. METHODS: Patients hospitalized for high-risk PE between 2016 and 2019 were identified by administrative claims codes from the National Readmission Database. Therapy assignment was similarly defined by administrative codes, then stratified into NLT, ST, and CDT cohorts to report patient characteristics, care settings, and clinical outcomes. The primary outcome was in-hospital mortality with rates adjusted for patient and hospital characteristics using multivariable logistic regression. Secondary outcomes included intracranial hemorrhage (ICH), gastrointestinal bleeding (GIB), and 90-day readmission. Over the years of interest, trends in lytic treatment along with concomitant use of mechanical or surgical thrombectomy were reported. RESULTS: Among 74,516 patients with high-risk PE, 61,569 (82.6%) received NLT, 8445 (11.3%) received ST, and 4502 (6.04%) received CDT. The NLT subgroup, relative to ST and CDT, tended to be older (66.1 ± 15.4, 62.8 ± 15.3, and 63.4 ± 14.4; p < 0.001) and more frequently women (56.0%, 54.4%, and 51.3%; p < 0.001), respectively. The unadjusted in-hospital mortality rate was highest for ST (18.8%, 34.1%, and 18.3% for NLT, ST, and CDT, respectively; p < 0.001) and persisted after multivariable adjustment (adjusted odds ratio (aOR) 0.43; 95% CI 0.38-0.49; p < 0.0001) of in-hospital mortality for CDT relative to ST. The unadjusted rate of ICH or GIB was lowest for NLT (1.0%, 2.0%, and 0.6% for NLT, ST, and CDT, respectively; p < 0.001). CDT, relative to ST, was associated with reduced odds of ICH (aOR 0.32; 95% CI 0.18-0.55; p < 0.0001) and GIB (aOR 0.78; 95% CI 0.62-0.98; p < 0.0001). Readmissions were highest for NLT (21.7%, 9.6%, and 12.1% for NLT, ST, and CDT, respectively; p < 0.001). CDT was associated with a higher incidence of 90-day readmission relative to ST (aOR 1.32; 95% CI 1.10-1.57; p < 0.001). From 2016 to 2019, individual treatment trends were not significantly different, although NLT tended to be offered among smaller and rural hospitals. Rates of concomitant thrombectomy were low in all three treatment groups. CONCLUSIONS: Among a large, contemporary, US cohort with high-risk PE, over 80% of patients did not receive any form of thrombolysis. High-risk PE that did receive systemic thrombolysis was associated with the highest rates of in-hospital mortality, suggesting opportunities to study the implementation of lytic and nonlytic-based treatments to improve outcomes for those presenting with high-risk PE.

Cardiovascular disease burden in the Middle East and North Africa region.

INTRODUCTION: Cardiovascular disease (CVD) remains the leading cause of death globally, including the Middle East and North Africa (MENA) region. However, limited research has been conducted on the burden of CVD in this region. Our study aims to investigate the burden of CVD and related risk factors in the MENA. METHODS: We used data from the Global Burden of Disease (GBD) 2019 to examine CVD prevalence in 21 MENA countries. Prevalence and mortality were analyzed using Bayesian regression tools, demographic methods, and mortality-to-incidence ratios. Disability-adjusted life years (DALYs) were calculated, and risk factors were evaluated under the GBD's comparative risk assessment framework. RESULTS: Between 1990 and 2019, CVD raw accounts in the MENA increased by 140.9%, while age standardized prevalence slightly decreased (-1.3%). CVD raw mortality counts rose by 78.3%, but age standardized death rates fell by 28%. Ischemic heart disease remained the most prevalent condition, with higher rates in men, while women had higher rates of CVA. Age standardized DALYs decreased by 32.54%. DALY rates varied across countries and were consistently higher in males. Leading risk factors included hypertension, high LDL-C, dietary risks, and elevated BMI.  The countries with the three highest DALYs in 2019 were Afghanistan, Egypt, and Yemen. CONCLUSIONS: While strides have been made in lessening the CVD burden in the MENA region, the toll on mortality and morbidity, particularly from ischemic heart disease, remains significant. Country-specific variations call for tailored interventions addressing socio-economic factors, healthcare infrastructure, and political stability.

Incidence and Cross-Continents Differences in Endoscopic Retrograde Cholangiopancreatography Outcomes Among Patients With Cirrhosis: A Systematic Review and Meta-Analysis.

Background: There are conflicting data on the frequency and variability of endoscopic retrograde cholangiopancreatography (ERCP) outcomes in patients with cirrhosis. Our aim was to systematically review the literature on the incidence of post-ERCP adverse events in cirrhotic patients and to examine the differences across continents. Methods: We searched PubMed/MEDLINE, EMBASE, Scopus, and Cochrane databases to identify studies reporting adverse events after ERCP in patients with cirrhosis from conception to September 30, 2022. The random effects model was used to calculate odds ratios (ORs), mean differences (MDs), and confidence intervals (CIs). A P value < 0.05 was considered statistically significant. Heterogeneity was assessed using the Cochrane Q-statistic (I2). Results: Twenty-one studies that included 2,576 cirrhotic patients and 3,729 individual ERCPs were analyzed. The pooled overall rate of adverse events after ERCP in patients with cirrhosis was 16.98% (95% CI: 13.06-21.29%, P < 0.001, I2 = 86.55%). ERCPs performed in Asia had the highest ERCP adverse events with an overall complication rate of 19.90%, while the lowest overall adverse events were in North America at 13.04%. The pooled post-ERCP bleeding, pancreatitis, cholangitis and perforation were 5.10% (95% CI: 3.33-7.19%, P < 0.001, I2 = 76.79%), 3.21% (95% CI: 2.20-5.36%, P = 0.03, I2 = 42.25%), 3.02% (95% CI: 1.19-5.52%, P < 0.001, I2 = 87.11%), and 0.12% (95% CI: 0.00 - 0.45, P = 0.26, I2 = 15.76%), respectively. The pooled post-ERCP mortality rate was 0.22% (95% CI: 0.00-0.85%, P = 0.01, I2 = 51.86%). Conclusions: This meta-analysis shows that the overall complication rates after ERCP, bleeding, pancreatitis, and cholangitis are high in patients with cirrhosis. Because cirrhotic patients are more likely to have post-ERCP complications, with significant cross-continent variations, the risks and benefits of ERCP in this patient population should be carefully considered.

Hospital Procedural Volume and Clinical Outcomes Following Septal Reduction Therapy in Obstructive Hypertrophic Cardiomyopathy.

Background Prior national data showed a substantial in-hospital mortality in septal myectomy (SM) with an inverse volume-outcomes relationship. This study sought to assess the contemporary outcomes of septal reduction therapy and volume-outcome relationship in obstructive hypertrophic cardiomyopathy. Methods and Results All septal reduction therapy admissions between 2010 to 2019 in the United States were analyzed using the National Readmission Databases. Hospitals were stratified into tertiles of low-, medium-, and high-volume based on annualized procedural volume of alcohol septal ablation and SM. Of 19 007 patients with obstructive hypertrophic cardiomyopathy who underwent septal reduction therapy, 12 065 (63%) had SM. Two-thirds of hospitals performed ≤5 SM or alcohol septal ablation annually. In all SM encounters, 482 patients (4.0%) died in-hospital post-SM. In-hospital mortality was <1% in 1505 (88.4%) hospitals, 1% to 10% in 30 (1.8%) hospitals, and ≥10% in 167 (9.8%) hospitals. There were 63 (3.7%) hospitals (averaging 2.2 SM cases/year) with 100% in-hospital mortality. Post-SM (in low-, medium-, and high-volume centers, respectively), in-hospital mortality (5.7% versus 3.9% versus 2.4%, P=0.003; adjusted odds ratio [aOR], 2.86 [95% CI, 1.70-4.80], P=0.001), adverse in-hospital events (21.30% versus 18.0% versus 12.6%, P=0.001; aOR, 1.88 [95% CI, 1.45-2.43], P=0.001), and 30-day readmission (17.1% versus 12.9% versus 9.7%, P=0.001; adjusted hazard ratio, 1.53 [95% CI, 1.27-1.96], P=0.001) were significantly higher in low- versus high-volume hospitals. For alcohol septal ablation, the incidence of in-hospital death and all other outcomes did not differ by hospital volume. Conclusions In-hospital SM mortality was 4% with an inverse volume-mortality relationship. Mortality post-alcohol septal ablation was similar across all volume tertiles. Morbidity associated with SM was substantial across all volume tertiles.

Clinical Outcomes of Revascularization with Percutaneous Coronary Intervention Prior to Transcatheter Aortic Valve Replacement: A Comprehensive Meta-Analysis.

BACKGROUND: Prior studies on revascularization prior to transcatheter aortic valve replacement (TAVR), in patients with significant coronary artery disease (CAD), have reported mixed results. AIM: We sought to perform a meta-analysis combining current evidence by investigating outcomes of revascularization in patients who undergo TAVR with coexisting CAD. METHODS: We searched literature for studies reporting on outcomes following TAVR performed with versus without pre-TAVR PCI, for coexisting CAD. Random-effect model was used to pool estimates of odds ratios (ORs). RESULTS: Twenty-four reports with 12,182 TAVR patients were included: 22 observational and 2 clinical trials. 4,110 (33.7%) were in the pre-TAVR PCI group, 51.4% were females, and mean age was 81.9 years. The 30-day mortality was 5.2% versus 5.0% in patients with versus without pre-TAVR PCI, respectively [OR= 1.19 (95% CI: 0.91-1.55, P= 0.20)]. Pooled 1-year mortality was 18.1% versus 19.1% in patients with versus without pre-TAVR PCI (OR= 1.12, 95% CI: 0.95-1.31, P= 0.61). There was no significant difference between the groups for myocardial infarction, stroke, acute kidney injury, pacemaker implantation, or re-hospitalization. Pre-TAVR PCI was associated with an increased risk of life-threatening bleeding at 30 days. CONCLUSION: Pre-TAVR revascularization with PCI was not associated with improved 30-day or 1-year mortality; however, it was associated with an increased risk of life-threatening bleeding at 30-day post-TAVR. Our results do not support routine revascularization with PCI prior to TAVR with coexisting CAD. Future trials addressing anatomical complexity and symptom burden may help better risk stratify patients who may benefit from pre-TAVR revascularization.